Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-85
SponsorAnaconda Biomed S.L.
About this trial
The objective of this study is to assess the safety and effectiveness of mechanical thrombectomy (MT) using the ANA funnel catheter in its intended use, which is to facilitate the navigation and deployment of other neurovascular devices and to allow flow arrest during mechanical thrombectomy procedures performed in subjects experiencing acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) and treated within 24 hours of symptom onset.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 22 to 85 years.
Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative).
A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
Baseline NIHSS obtained prior to procedure ≥ 6 points and ≤ 25 points.
Disqualifiers
Subject was diagnosed with a stroke in the past year.
Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
Known hemorrhagic diathesis, coagulation factor deficiency, oral anticoagulant therapy with antivitamin K, with INR >3.0, or thrombocytopenia - baseline platelet count < 50,000 platelets/mL.
Known baseline glucose of <50 mg/dL or >400 mg/dL.
Trial design
Design model
Parallel
Treatments tested in this trial
ANA Funnel Catheter
DeviceMechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed.
Control
DeviceMechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques.
Treatment groups
327 Participants
are divided into 2 treatment groupsGroup A: ANA Funnel Catheter GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects with "near-complete" reperfusion after one thrombectomy pass (FPE, eTICI 2c-3, extended Thrombolysis in Cerebral Infarction scale) in the target vessel.
Reperfusion (eTICI 2c-3) to be assessed by an independent Core Lab.
Time frame
intra-operative2
Rate of symptomatic intracranial hemorrhage (sICH), attributable to the device or procedure.
Extent of hemorrhage to be assessed by an independent Core Lab, symptoms to be assessed by the Data Monitoring Committee (DMC).
Time frame
Within 24 hours of the procedureSponsors and contacts
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Source ClinicalTrials.gov